BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDER TOUCH VACUUM EXTRACTOR CUP

    MDR report key: 232106 · Received July 16, 1999

    Report

    Report Number
    232106
    Event Type
    Death
    Date Received
    July 16, 1999
    Date of Event
    July 6, 1999
    Report Date
    July 16, 1999
    Manufacturer
    UTAH MEDICAL PRODUCTS
    Product Code
    HDB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A 37-38 WK MALE INFANT DELIVERED BY STAT VACUUM EXTRACTION FOR DECELERATIONS WITH APGAR OF 5/8. THE INFANT WAS BORN WITH NUCHAL CORD X 1 EXTREMELY TIGHT. PT HAD WEAK RESPIRATORY EFFORT, VERY LARGE CAPUT, WEAK CRY, PALLOR, AND GRUNTING RESPIRATIONS. HE REQUIRED INTUBATION AND PLACEMENT ON VENTILATOR. A CT SCAN OF THE HEAD REVEALED EXTENSIVE SUBGALEAL HEMORRHAGE, DIFFUSE CEREBRAL EDEMA, BUT NO FRACTURES. THE SETTINGS ON THE PUMP USED FOR THE EXTRACTION WERE 500MM/HG X 2 ATTEMPTS FOR 10 AND 15 SECONDS, DISCONTINUED AND REAPPLIED WITH SETTING AT 500MM/HG X 3 FOR 10-20 SECONDS DURING A CONTRACTION. THE INFANT'S CONDITION RAPIDLY DETERIORATED IN NICU AND REQUIRED RESUSCITATION DUE TO BRADYCARDIA AND HYPOTENSION SECONDARY TO HYPOVOLEMIC SHOCK. THE INFANT EXPIRED ON 7/7/99. THIS WAS A VERTEX PRESENTATION AND THE MOTHER HAD RECEIVED REGULAR PRENATAL CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDER TOUCH VACUUM EXTRACTOR CUP OBSTETRICAL VACUUM DELIVERY KIT HDB UTAH MEDICAL PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Death| H| L| R